Advanced Refractory Left Ventricular Heart Failure
Conditions
Brief summary
This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS). The objective of this study is to evaluate the implantation of the HM3 utilizing techniques other than full median sternotomy (e.g. thoracotomy) and impact on post-implant length of stay.
Interventions
DEVICEHeartMate 3 Left Ventricular Assist System (HM3 LVAS)
This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy.
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject or Legal Representative has provided written informed consent by signing the study Informed Consent Form (ICF) 2. Subject must be ≥ 18 years of age at the time of informed consent 3. Subject is receiving the HM3 as their first LVAD 4. Body surface area (BSA) ≥ 1.2m2 5. Subject is NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV 6. LVEF ≤ 25% 7. Subject is: 1. Inotrope dependent OR 2. Has CI\<2.2 L/min/m2, while not on inotropes and meets one of the following criteria: * On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond to therapy * Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days 8. Females of child bearing age must agree to use adequate contraception
Exclusion criteria
1. Subject has a planned concomitant procedure at time of implant (e.g. valve repair, CABG, ASD repair, etc) 2. Subject has greater than mild aortic insufficiency 3. Physiologically significant (i.e. requires intervention) atrial septal defect 4. Subject has severe right heart failure (RHF) (refer to Appendix 2 for guidance) 5. Subject has planned Bi-VAD support prior to enrollment 6. Presence of mechanical aortic valve that will not be either converted to bioprosthesis or oversewn at the time of LVAD implant 7. Subject has ongoing mechanical circulatory support (MCS) at the time of LVAD surgery other than IABP 8. Subject has a history of any organ transplant 9. Positive pregnancy test 10. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy 11. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator 12. Platelet count \< 100,000 x 103/L (\< 100,000/ml) 13. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management 14. History of confirmed, untreated AAA \> 5 cm in diameter within 6 months of enrollment 15. Presence of an active, uncontrolled infection 16. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the subjects' health status 17. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: 1. An INR ≥ 2.0 not due to anticoagulation therapy 2. Total bilirubin \> 43 μmol/L (2.5 mg/dl) or biopsy-proven liver cirrhosis 3. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC \< 0.7, and FEV1 \<50% predicted 4. Fixed pulmonary hypertension with most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention 5. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (\> 80%) uncorrected carotid stenosis 6. Serum creatinine ≥ 221 μmol/L (2.5 mg/dl) or the need for chronic renal replacement therapy 7. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration 18. Pre-albumin \< 150mg/liter (15 mg/dl) or albumin \<30 g/liter (3g/dl) (if only one available); pre-albumin \<150mg/liter (15 mg/dl) and albumin \<30 g/liter (3 g/dl) (if both available) 19. Subject has known hypo- or hyper-coagulable states such as disseminated intravascular coagulation and heparin-induced thrombocytopenia 20. Participation in any other clinical investigation that is likely to confound study results or affect the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients surviving at 6 months free of debilitating stroke (Modified Rankin Score > 3), device malfunction requiring re-operation to replace or remove the device, or conversion of the implant surgical approach to open sternotomy. | 6 Months | The composite primary endpoint of the study is survival at 6 months free of debilitating stroke (Modified Rankin Score \> 3), device malfunction requiring re-operation to replace or remove the device, or conversion of the implant surgical approach to open sternotomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Initial hospital stay, approximately 3 weeks | Mean length of hospital stay from implant to hospital discharge |
Countries
Canada, United States
Outcome results
None listed